Non-blooming gelatin and non-gelatin formulations

Abstract

A non-blooming plasticizer composition and methods of using the composition are described herein. The composition is a mixture of sorbitol and sorbitan wherein the ratio of sorbitan and sorbitol is between about 0.40 and about 1.2 by weight, more preferably from about 0.45-0.50 to about 0.70 by weight, wherein the composition contains less than 20% of other dextrose hydrolytic degradation products. The non-blooming plasticizer compositions can be mixed, alone or in combination with other shell additives, with gelatin or non-gelatin materials to prepare soft capsules for the delivery of pharmaceutical, nutritional and personal care products, such as bath oils, shampoos and conditioners, and skin lotions.

1 . A non-blooming gelatin and non-gelatin plasticizer composition comprising a mixture of sorbitol and sorbitan wherein the ratio of sorbitan to sorbitol is between about 0.40 and about 1.2 by weight and wherein the composition comprises less than 20% of other dextrose hydrolytic degradation products.  
   
   
       2 . The composition of  claim 1 , wherein the ratio of sorbitan to sorbitol is 0.50 to 0.70 by weight.  
   
   
       3 . The composition of  claim 1  wherein the composition comprises other plasticizers selected from the group consisting of glycerin, propylene glycol or maltitol.  
   
   
       4 . A method of making a non-blooming soft capsule shell comprising providing in the soft capsule shell composition a plasticizer comprising a mixture of sorbitol and sorbitan wherein the ratio of sorbitan to sorbitol is between about 0.40 and about 1.2 by weight and wherein the composition comprises less than 20% of other dextrose hydrolytic degradation products.  
   
   
       5 . The method of  claim 4  further comprising encapsulating a fill material in the soft capsule shell.  
   
   
       6 . The method of  claim 4  wherein the soft capsule shell composition comprises the plasticizer and gelatin.  
   
   
       7 . The method of  claim 4 , wherein the ratio of sorbitan to sorbitol is between about 0.50 and 0.70 by weight.  
   
   
       8 . A soft gel capsule for making a pharmaceutical dosage form comprising a non-blooming plasticizer composition comprising a mixture of sorbitol and sorbitan wherein the ratio of sorbitan to sorbitol is between about 0.40 and about 1.2 by weight and wherein the composition comprises less than 20% of other dextrose hydrolytic degradation products.  
   
   
       9 . The soft gel capsule of  claim 8 , wherein the ratio of sorbitan to sorbitol is 0.50 to 0.70 by weight.  
   
   
       10 . The soft gel capsule of  claim 8  wherein the soft capsule shell further comprises other plasticizers selected from the group consisting of glycerin, propylene glycol or maltitol.  
   
   
       11 . The soft gel capsule of  claim 8  wherein the soft capsule shell comprises gelatin.  
   
   
       12 . The soft gel capsule of  claim 8  comprising at least one pharmaceutically active agent in a therapeutically effective amount encapsulated in the soft capsule shell.  
   
   
       13 . The soft gel capsule of  claim 12  wherein the agent is selected from the group consisting of analgesics, anti-inflammatory agents, antihelmintics, anti-arrhythmic agents, anti-bacterial agents, anti-viral agents, anti-hypertensive agents, anti-coagulants, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-malarials, anti-migraine agents, anti -muscarinic agents, anti-neoplastic agents, erectile dysfunction improvement agents, immunosupressants, anti-protozoal agents, anti-thyroid agents, anxiolytic agents, sedatives, hypnotics, neuroleptics, β-blockers, cardiac inotropic agents, corticosteroids, diuretics, anti-parkinsonian agents, gastro-intestinal agents, histamine H 1  and H 2  receptor antagonists, keratolytics, lipid regulating agents, anti-anginal agents, nutritional agents, opioid analgesics, sex hormones, stimulants, muscle relaxants, anti-osteoporosis agents, anti-obesity agents, cognition enhancers, anti-urinary incontinence agents, nutritional oils, anti-benign prostate hypertrophy agents, essential fatty acids, non essential fatty acids, vitamins, minerals and mixtures thereof.